In a 6-year open-label study

In a randomized, double-blind, placebo-controlled multicenter study of 625 patients comparing FLOMAX 0.4 mg vs alfuzosin 10 mg and 15 mg:

Proven Tolerability

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Important Safety Information
FLOMAX is indicated to treat the signs and symptoms of benign prostatic hyperplasia (BPH). FLOMAX is not indicated to treat hypertension. As with other alpha-adrenergic blocking agents, there is a potential risk of syncope. Patients beginning treatment with FLOMAX should be cautioned to avoid driving or hazardous tasks for 12 hours after their first dose or increase in dose should syncope occur. The most common side effects are dizziness, abnormal ejaculation, and rhinitis.

Caution should be exercised with concomitant administration of warfarin and FLOMAX. In addition, FLOMAX should be used with caution in combination with cimetidine, particularly at doses higher than 0.4 mg. FLOMAX is contraindicated in patients known to be hypersensitive to tamsulosin HCl or any component of FLOMAX.

Before prescribing FLOMAX, please see the full Prescribing Information.

* In 2 European, 12-week, randomized, placebo-controlled clinical trials.

† US placebo-controlled registration trials 92-03A and 93-01.


1. Data on file, Boehringer Ingelheim Pharmaceuticals, Inc.

2. Center for Drug Evaluation and Research. Food and Drug Administration Web site. Available at: http://www.fda.gov/cder/foi/nda/2003/21-287_uroxatral_medr_p2.pdf. Accessed September 16, 2005.

3. Höfner K, Claes H, De Reijke TM, et al, for the European Tamsulosin Study Group. Tamsulosin 0.4 mg once daily: effect on sexual function in patients with lower urinary tract symptoms suggestive of benign prostatic obstruction. Eur Urol. 1999;36:335-341.

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